Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical...
Source: jdsupra.com
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Why Shares of Surmodics Soared on Tuesday
An analyst upgrade gave the stock a boost.
Source: fool.com
Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA ... | March 28, 2023
Source: marketscreener.com
Surmodics Gets FDA Request for Clarification of SurVeil Drug-Coated Balloon
By Chris Wack Surmodics Inc. said Tuesday it has received formal feedback from the U.S. Food and Drug Administration related to its proposed approach to submit an amended premarket approval... | March 28, 2023
Source: marketscreener.com
Surmodics Shares Rise 11% After FDA Request for SurVeil Drug-Coated Balloon Info
By Chris Wack Surmodics Inc. shares were up 11% at $21.34 after the company said Tuesday it has received formal feedback from the U.S. Food and Drug Administration related to its proposed... | March 28, 2023
Source: marketscreener.com